Tranexamic Acid for Upper Gastrointestinal Bleeding (TAUGIB)

Seoul National University

Status and phase: Unknown; Phase 3

Conditions: Acute Upper Gastrointestinal Hemorrhage

Treatments: Drug: Early intravenous tranexamic acid administration; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01713101

B-1207-163-002

Details and patient eligibility

About

This study is to see whether the early intravenous administration of tranexamic acid improves the outcome of acute upper gastrointestinal bleeding.

Full description

Previous studies reported that IV/Oral administration of tranexamic acid improves the outcome upper gastrointestinal bleeding. However, the drug is scarcely used nowadays as those studies are outdated in present clinical field where early endoscopic treatment and PPI administration are considered norm. Although a recent meta-analysis done by Cochrane review group concluded that it improves patient survival, other review articles including "Gut" suggested that a well-designed clinical study is needed for re-evaluation of the efficacy and safety of the drug in current clinical situation. We hypothesized that early administration of the drug will significantly decrease the proportion of patient requiring early endoscopic treatment.

Enrollment: 414 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Chief complaint of hematemesis, melena or hematochezia
2. and objective signs of upper gastrointestinal bleeding

Exclusion criteria

1. Pregnant woman, age less than 18

2. Patients whose use of the study drug is contraindicated

   • Increased thromboembolic risk

     • History of thromboembolic disease
     • Alleged inherited thrombophilic disorders
     • Malignancy (except those cured and has not recurred more than two years)
     • Nephrotic syndrome
     • Estrogen use
     • Pregnancy
     • HIT, APA

   • High-risk for cardioembolism

     • Underlying structural heart disease where anticoagulation is indicated
     • Underlying cardiac rhythm disorder where anticoagulation is indicated (e.g. atrial fibrillation/flutter)

   • Possibilities of ongoing DIC

     • Signs and symptoms suggestive of clinically significant infectious disease (e.g. body temperature > 38 degree)
     • Any malignancy except those cured and has not recurred more than two years

   • Patients with history or presence of subarachnoid hemorrhage

   • Acquired color vision impairment, visual loss and retinal venous and arterial occlusions

   • Past history of seizure or organic brain lesion that predispose to seizure disorder

3. Previous history of variceal bleeding

4. Cases where informed consent is unobtainable

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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414 participants in 2 patient groups, including a placebo group

Early intravenous tranexamic acid administration

Experimental group

Description:

Early intraveous administration of tranexamic acid (1g IV bolus over 10 minutes followed by 1g slow infusion over 8 hours

Treatment:

Drug: Early intravenous tranexamic acid administration

Placebo group

Placebo Comparator group

Description:

Normal saline (placebo) administration instead of tranexamic acid solution

Treatment:

Drug: placebo